A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions.   Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at ...

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper . The ratings would be publicly available.   “QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for s...

A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) details the top drug quality issues seen in from 2016-2020, with questions of product quality topping the list.   In all, just over a quarter (27%) of all Product Quality Defect (PQD) reports were related to product quality issues, while device and packaging issues together made up another third of the PDQ reports over the 5-year period.   The PQD reports came fro...

Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...

The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on Thursday, highlighting its effort in a year marked by the COVID-19 pandemic.   In its previous annual report, the Office of Pharmaceutical Quality (OPQ) touted its participation in nearly one third of the preapproval inspections FDA carried out in 2019. For 2020, OPQ instead foc...

The US Food and Drug Administration said Thursday that the planned reorganization of its Office of New Drugs (OND) will move forward thanks to Congressional approval, including changes to its Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ). The changes will create offices for interrelated disease areas and divisions with clearer and more focused expertise, FDA said , noting the number of OND offices that oversee its review division...

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.   OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviat...

A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise. The finding stems from an analysis published Monday in Nature Nanotechnology , in which the officials look at trends in submissions involving nanomaterials over the last 40 years. In the analysis, the authors say the number of investigation...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes. The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical test...

The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment. The 10-page guide follows the creation of an Office of Pharmaceutical Quality , the release of draft guidance for industry, known...

The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals. The Future of Quality FDA has been and continues to be committed to assuring quality (i.e., safety and efficacy) medicines are available to the American public. FDA implemented quality o...

The US Food and Drug Administration (FDA) has big plans to boost the quality of pharmaceutical products through the creation of its new Office of Pharmaceutical Quality (OPQ). But its success perhaps depends on one factor more than any other: Finding the right person to lead the effort. Background The creation of OPQ was  first announced  in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research (CDER) by longtime Director Janet W...